Overview:
Through this presentation, you will develop a comprehensive understanding of the Drug Approval Process and in parallel examine major misconceptions and misunderstandings.
Why should you Attend:
We will share insights and practical examples that facilitate a positive, ...

Overview:
Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency.
Why should you ...

Overview:
Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.
Why should you Attend:
This webinar will cover the key areas of how ICH Q7 was established, ...

Overview:
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.
Why should you Attend:
Accounting and finance is ...

Overview:
This 60-min webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Why should you ...

Overview:
This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety.
Why should you Attend:
Consumer Safety is paramount in the food industry, ...

Overview:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Why should you Attend:
Verification and validation requirements have ...

Overview:
How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?
Why should you Attend:
What are the changes to the technical and ...

Overview:
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the ...

Overview:
These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
Why should you Attend:
Part 11 / Annex 11 Computer Systems Validation (CSV) is to ...

Overview:
One big issue is how you patrol and control what someone else is saying about your product in a public forum. Once the off-label information is out there, what is scope your responsibility?
Why should you Attend:
What is considered "off-label"
Using social media website ...

Overview:
The focus will be on drugs, biologics and medical devices, We will also be providing an overview of how the regulatory landscape is currently evolving for most efficient strategic planning.
Why should you Attend:
This webinar will give you a snap shot of what is current, ...

Overview:
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Why should you Attend:
This session will discuss how to prepare for ...